Why the FDA should be charged with murder

If you worked for a federal agency that was killing people at the rate of 100,000 a year, every year, like clockwork, and if you knew it, wouldn’t you feel compelled to say or do something about it?

At the FDA, which is, in fact, killing Americans at that rate, no one has ever felt the need to step forward and speak up.

Let’s shift the venue and ask the same question. If you were a medical reporter for a major media outlet in the US, and you knew the above fact, wouldn’t you make it a priority to say something, write something, do something?

Lenzer refers to a report by the Institute for Safe Medication Practices: “It calculated that in 2011 prescription drugs were associated with two to four million people in the US experiencing ‘serious, disabling, or fatal injuries, including 128,000 deaths.'”

The report called this “one of the most significant perils to humans resulting from human activity.”

And here is the final dagger. The report was compiled by outside researchers who went into the FDA’s own database of “serious adverse [medical-drug] events.”

Therefore, to say the FDA isn’t aware of this finding would be absurd. The FDA knows. The FDA knows and it isn’t saying anything about it, because the FDA certifies, as safe and effective, all the medical drugs that are routinely maiming and killing Americans.

Previously, I have documented that the FDA knows; because the FDA has a page on its own website that admits 100,000 people are killed every year by medical drugs, and two million more people are severely injured by the drugs. (Google “FDA Why Learn About Adverse Drug Reactions”)

And for the past five years or so, I have been writing about and citing a published report by the late Dr. Barbara Starfield that indicates 106,000 people in the US are killed by medical drugs every year. Until her death in 2011, Dr. Starfield worked at the Johns Hopkins School of Public Health. Her report, “Is US health really the best in the world?”, was published in the Journal of American Medical Association on July 26, 2000.

Since the Department of Homeland Security is working its way into every nook and corner of American life, hyper-extending its mandate to protect all of us from everything, why shouldn’t I go along with Janet Napolitano’s advice: see something, say something.

This is what I see and this is what I’m saying. Maybe DHS would like to investigate the FDA as a terrorist organization.

How many smoking guns do we need before a sitting president shuts down the FDA buildings, fumigates the place, and prosecutes very large numbers of FDA employees?

Do we need 100,000 smoking guns every year? Do we need relatives of the people who’ve all died in the span of merely a year, from the poisonous effects of FDA-approved medical drugs, to bring their corpses to the doors of FDA headquarters?

And let me ask another question. If instead of drugs like warfarin, dabigatran, levofloxacin, carboplatin, and lisinopril (the five leading killers in the FDA database), the 100,000 deaths per year were led by gingko, ginseng, vitamin D, niacin, and raw milk, what do you think would happen?

I’ll tell you what would happen. SEALS, Delta Force, SWAT teams, snipers, predator drones, tanks, and infantry would be attacking every health-food store in America. The resulting fatalities would be written off as necessary collateral damage in the fight to keep America safe and healthy.

All those phony stories in the press, reported dutifully by so-called medical reporters? The stories about maybe-could-be-possible-miracle breakthroughs just over the horizon of state-of-the-art medical research? Those stories are there to obscure the very, very hard facts of medically-caused death on the ground.

The buck stops at the FDA.

Except in the real world, it doesn’t. Which tells you something about the so-called real world and how much of it is composed of propaganda.

Here is the situation. No medical drug in the US can be released for public use unless and until the FDA says it is safe and effective. That’s the rule. The FDA is spitting out drug approvals month after month and year after year, and the drugs are routinely killing 100,000 people a year and maiming two million more, which adds up to a million deaths per decade and 20 million maimings per decade. The FDA and the federal government are doing nothing about it, even though they know what’s going on. This is mass murder. Not accidental death. Murder. A holocaust.

Stephen Hawking Visits LA Stem Cell Lab

Stephen Hawking, listens to Robert H. Baloh, MD, PhD, the Director of Neuromuscular Medicine in the Department of Neurology, as he was given a tour of the Regenerative Medicine Institute at Cedars-Sinai Medical Center, April 9, 2013, in Los Angeles. (Eric Reed/AP)

Stephen Hawking is one of the greatest minds of our time and he has lived 50 years with ALS. Stem cell treatments have a proven history of treatment of ALS in both animal and human studies.

“… What, in fact, we found is – and this reflected a growing sophistication of our knowledge about stem cells as well as a growing sophistication about our knowledge about ALS – that the stem cells did make a difference in these animals. It slowed the onset of the disease, its progression and prolonged survival fairly significantly. But it did it by protecting the neurons of this animal and also kind of counteracting many of the other disease processes that we started learning were going on in this disease.”

“Injecting stem cells into the brains of mice that recently suffered a stroke can reduce nerve cell (neuron) damage by up to 60 percent, according to new research. But the stem cells do not simply replace damaged tissue as previously believed. Instead, the immature cells trigger adult brain cells to switch gears and block a stroke-induced immune response that causes nerve damage.”

By ALICIA CHANG AP Science Writer

LOS ANGELES April 10, 2013 (AP)

Stephen Hawking toured a stem cell laboratory Tuesday where scientists are studying ways to slow the progression of Lou Gehrig’s disease, a neurological disorder that has left the British cosmologist almost completely paralyzed.

After the visit, the 71-year-old Hawking urged doctors, nurses and staff at Cedars-Sinai Medical Center to support the research.

Hawking recalled how he became depressed when he was diagnosed with the disease 50 years ago and initially didn’t see a point in finishing his doctorate. But his attitude changed when his condition didn’t progress quickly and he was able to concentrate on his studies.

“Every new day became a bonus,” he told a packed room.

Cedars-Sinai received nearly $18 million last year from California’s taxpayer-funded stem cell institute to study the debilitating disease also known as amyotrophic lateral sclerosis. ALS attacks nerve cells in the brain and spinal cord that control the muscles. People gradually have more and more trouble breathing and moving as muscles weaken and waste away.

There’s no cure and no way to reverse the disease’s progression. Few people with ALS live longer than a decade.

Diagnosed at age 21 while a student at Cambridge University, Hawking has survived longer than most. He receives around-the-clock care, can only communicate by twitching his cheek, and relies on a computer mounted to his wheelchair to convey his thoughts in a distinctive robotic monotone.

A Cedars-Sinai patient who was Hawking’s former student spurred doctors to invite the physicist to glimpse their stem cell work.

“We decided it was a great opportunity for him to see the labs and for us to speak to one of the preeminent scientists in the world,” said Dr. Robert Baloh, who heads the hospital’s ALS program.

During the tour, Hawking viewed microscopic stem cells through a projector screen and asked questions about the research, Baloh said.

Cedar-Sinai scientists have focused on engineering stem cells to make a protein in hopes of preventing nerve cells from dying. The experiment so far has been done in rats. Baloh said he hopes to get governmental approval to test it in humans, which would be needed before any therapy can be approved.

Renowned for his work on black holes and the origins of the universe, Hawking is famous for bringing esoteric physics concepts to the masses through his best-selling books including “A Brief History of Time,” which sold more than 10 million copies worldwide. Hawking titled his speech to Cedars-Sinai employees “A Brief History of Mine.”

Despite his diagnosis, Hawking has remained active. In 2007, he floated like an astronaut on an aircraft that creates weightlessness by making parabolic dives.

Space exploration is important “for the future of humanity,” he told the audience.

Hawking said he did not think Earthlings would survive “without escaping beyond your fragile planet.”

And he gave some advice: Look up at the stars. Stay curious.

“However difficult life may seem, there is always something you can do and succeed at,” he said.

Doctors don’t know why some people with Lou Gehrig’s disease fare better than others. Baloh said he has treated patients who lived for 10 years or more.

Mar. 12, 2013 — In laboratory studies, Johns Hopkins researchers say they have found that stem cells from a patient’s own fat may have the potential to deliver new treatments directly into the brain after the surgical removal of a glioblastoma, the most common and aggressive form of brain tumor.

The investigators say so-called mesenchymal stem cells (MSCs) have an unexplained ability to seek out damaged cells, such as those involved in cancer, and may provide clinicians a new tool for accessing difficult-to-reach parts of the brain where cancer cells can hide and proliferate anew. The researchers say harvesting MSCs from fat is less invasive and less expensive than getting them from bone marrow, a more commonly studied method.

Adult Stem Cells: A Piece of My Heart, From Cells in My Arm

Doctors have dreamed of a day when science could grow healthy spare parts in a lab for the human body. A pivotal moment in this search came in the late ’90s when the first embryonic stem cells were isolated. These cells are the biological “seeds” that divide, differentiate and grow into the myriad parts of the human body. While it was a thrilling discovery, it was also the start of an ethical and political firestorm, since an embryo had to be destroyed in order to isolate its stem cells. In 2001, President George W. Bush signed an executive order to restrict further research.

The move forced scientists to search for other ways and in 2007, researchers in Japan and Wisconsin figured out a way to reprogram adult cells into stem cells. Word of the discovery reached Mayo, and Dr. Tim Nelson and his colleagues at the Center for Regenerative Medicine were intrigued. This could be a way to help all those kids, born with deformed hearts, who sit on transplant waiting lists at Mayo each year.

“This is one technology that allows us to understand disease, but it also allows us to dream about the day we apply that therapeutically.” And as he described his work, he made me a tantalizing offer. If I would agree to partake in their research, he said I “could be the first person to ever see his own heart tissue beat outside his body.”

It began with a biopsy of the skin under my left bicep, all the better to hide the tiny scar. With a small round knife, Dr. Nelson dug out a pencil eraser-sized chunk of my flesh and plopped it into a jar of pink liquid. I flew home and they went to work, using a combination of genes to bioengineer these bits of flesh into pluripotent (“many potentials”) stem cells. At that stage, they could’ve nudged them into becoming neurons or lung cells or even parts of my eyeball, but in keeping with Dr. Nelson’s promise, the Mayo team turned them into cardiac tissue. Months later, I returned for a one-of-a-kind reunion and gazing through that microscope, I could see pumping proof why this kind of medical science just won the Nobel Prize.

Dr. Nelson got most excited when he showed me a tiny piece of my cardiac tissue that had dramatically formed into the shape of a heart — a pumping, three-dimensional glimpse into a future when this kind of cell could theoretically be injected into a heart-attack victim or a diseased child and literally mend the person from within.

Two sisters have MS. I thought it would be interesting to see them both get stem cell treatments to see how their body’s and the stem cells reacted differently in such genetically similar people.- DG

A friend intelligently made the following comment:
“Even twins would have unique MS experiences. You have to consider multiple factors at play with MS symptoms. I know fraternal twins who experience the MS differently and have to be treated in different ways. There is no one-size-fits-all with having and treating MS.”

My response:
I agree there is no one treatment fits all but that is one of the unique attributes of stem cell treatments. Stem cells work within the systems of your own body, utilizing your own cells to regenerate and rejuvenate necrotic and damaged tissue, to create new tissue and to pull your own body’s healing elements into play to fix what is wrong. Stem cells, especially autologous (from your own body) stem cells used in therapy are a highly personalized individual treatment which will not only heal twins differently but will actually result in a different therapy each time the same person receives them depending upon what is currently needed by the body.

By analogy:

Imagine a drug is a big mack truck, driving along and crashing through anything in it’s way to attain it’s destination. Now imagine your own stem cells follow all of the rules of the road and even stop and fix damaged roadway on it’s way to it’s destination. The stem cells recruit helpers and construction workers and healers along the way and they will even build new roads if the area is too damaged to support the healing activity required.

Now imagine a batch of stem cells in a different country with different roads, signs, ailments etc and because they are part of the original healing system of that body, they are able to navigate, fix, recruit and heal there as well.

I agree 100%. THERE IS NO ONE TREATMENT FITS ALL. There is also no such thing as ONE STEM CELL TREATMENT.

Each stem cell treatment is unique to each individual. As they should be.
At least, the treatments I advocate are.

“I would like nothing more than to beleive adult stem cell working for different diseases, however I don’t. How can you take a sick cell and replant it and it becomes healthy.”

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My answer:

HIGH TURNOVER RATE
This is not magic, it is biological fact. Let’s start with your body. “Just like us, cells grow old and die. When old cells die, new ones replace them. For example, a blood cell in our body lives for about 120 days. Another example is our skin cells. We shed our skin cells about every 35 days.” That’s the outer layer which is why tattoos fade over time and why tattoos go deep into the lower levels of skin.

I’M DYING! YES, WE ALL ARE…
So our cells are in a constant state of “getting older” or “getting sick” or moving towards “impaired function.” I’m dying says the soldier with the sucking chest wound. Yes, we all are, says his philosopher friend. And we are indeed. “He not busy being born is busy dying.” says Bob Dylan. Perhaps this is too philosophical but the point is this: our body and every one of the 5-50 trillion cells is either getting older and weaker and dying or is currently being born or repaired. It’s a dynamic entity, this shell we reside in and it is constantly changing.

GETTING DOWN WITH THE SICKNESS
If you have too many cells with impaired function, especially in a specific area, which are damaged, necrotic, not getting enough nutrients, minerals etc and are getting exposure to too many toxins, inflammation, infections, etc which it can not eliminate, then something will go wrong and you will get sick with the capital ‘S’ and it is time to call in the workers to fix you up.

BOB THE BUILDER HAS SOME COMPETITIONStem cells are the body’s construction workers. They do both renovations and they do ground up construction. Renovations amount to taking dead tissue and cells – necrotic – and re-energizing them so they come back to life (no zombie jokes please). This can be seen in hundreds of heart studies and trials and thousands of congestive heart failure patients where necrotic heart tissue implanted with stem cells was found to be living and beating a few weeks later. Ground up construction is where they set up shop on a blank field and build something new. This can be seen when stem cells create mini bypasses where stents were implanted. They are actually smart enough to know the “stent area” is a dangerous heavy traffic area and even if the stent is working, they will create offramps and onramps around the stent or bypasses with capillaries. Pretty cool huh?

YOU CAN’T ALWAYS GET WHAT YOU WANT
Not magic, just plain old science and if your body was able to produce enough stem cells to run to the heart, it could do it by itself. In fact, it is trying, desperately to do exactly that but the body in congestive heart failure is like a single mother with 6 kids, 3 jobs and 2 dogs standing on one foot and juggling chain saws. She just can’t do it all, she is stretched to the limits of her endurance, something has to give…and it does. So while your body is sending stem cells to the heart, and the feet and the pancreas, liver, kidney, brain, endocrine and lymphatic and circulatory system infrastructure, RIGHT NOW, to renovate and build new cells and tissues, it is not sending ENOUGH and the fact that our single mom smokes and lives near a factory and does other people’s laundries, exposing herself to multiple chemical toxins, doesn’t sleep much, can only afford McD’s and is highly stressed, etc etc just taxes her body all the more.

RIGHT HERE, RIGHT NOW
So YOU have stem cells in YOUR body RIGHT NOW which are running around, differentiating into different cell types and healing you. All the time. So while our bodies are in a constant state of degradation, our stem cells are constantly fighting that degradation.

WANT THE SCIENCE?
If you would like trials and studies to back this up there are about 2,600 at last count and I can refer you to some that address a specific condition.

A cutting-edge method developed at the University of Michigan Center for Arrhythmia Research successfully uses stem cells to create heart cells capable of mimicking the heart’s crucial squeezing action.

Chicagoan Ieshea Thomas is the first Midwest patient to receive a successful stem cell transplant to cure her sickle cell disease without chemotherapy in preparation for the transplant. University of Illinois Hospital & Health Sciences System physicians performed the procedure using medication to suppress her immune system and one small dose of total body radiation right before the transplant.The transplant technique is relatively uncommon and is a much more tolerable treatment for patients with aggressive sickle cell disease who often have underlying organ disease and other complications, says Dr. Damiano Rondelli, professor of medicine at UIC, who performed Thomas’s transplant.

The procedure initially allows a patient’s own bone marrow to coexist with that of the donor. Since the patient’s bone marrow is not completely destroyed by chemotherapy or radiation prior to transplant, part of the immune defense survives, lessening the risk of infection. The goal is for the transplanted stem cells to gradually take over the bone marrow’s role to produce red blood cells — normal, healthy ones…